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Topography-guided LASIK: A paradigmshift in refractive laser treatment

www.eyeworld.orgSurgical innovations designedto improve outcomes

Supplement to EyeWorld Daily News, Monday, April 28, 2014 This supplement is sponsored by Alcon.

Refractive surgery has advanced significantly inthe past 2 decades. Whenit was first introduced, we were able to reduce

or eliminate patients’ dependenceon glasses or contact lenses. In ex-change for spectacle independence,however, patients sometimes had toaccept less than 20/20 uncorrectedvisual acuity (UCVA) and inducedvisual aberrations. Today, topogra-phy-guided treatment LASIK with the WaveLight Allegretto WaveEye-Q Laser (Alcon, Fort Worth,Texas) can provide not only freedomfrom glasses and contact lenses, butalso improved quality of vision.1

There are several differences between topography-guided customized LASIK and wavefront-guided customized LASIK. Wave-front-guided customized LASIK hastraditionally been based on wave-front measurements obtained byprojecting multiple light beams intothe eye and measuring the locationof the corresponding light reflectedfrom the retina. With topographers,we can measure many more pointsof curvature on the cornea over awider area than is possible withwavefront measurement devices. For example, the Topolyzer (Alcon),used in conjunction with the WaveLight Laser, measures cornealcurvature at approximately 22,000locations on the cornea, while theWaveLight wavefront analyzer(Alcon) measures only 168 sites, and the WaveScan (Abbott MedicalOptics, Santa Ana, Calif.) measuresonly 240 points per WaveScan technology specifications.

Another benefit of topographyis that measurements are not limitedby the pupil. Wavefront measure-ments require light to reach theretina through the pupil, so the size and location of the pupil limitsthe area that can be measured. In contrast, corneal topographicmeasurements can be applied to the entire cornea.

Additionally, highly aberratedeyes and those with corneal opaci-ties can produce inaccurate aberrom-eter measurements becauseaberrometers cannot always identifythe source of light leaving the eyeand because light may be scatteredby the corneal opacities. In contrast, topography-guided treatment can beused successfully to evaluate highlyaberrated eyes.

Aberrometer measurements arealso affected by the state of accom-modation (which can induce high-order aberrations in addition tospherical refractive changes), earlycataract, and vitreous opacities. Surgical correction of lenticularhigh-order aberrations can be problematic because they tend tochange with time. Additionally,wavefront-guided treatments do not necessarily compensate for off-axis rays of light passing throughlenticular opacities from different locations on the cornea.

Because corneal topographydoes not provide information aboutlow-order optical abnormalities ofthe eye—spherical error and regularastigmatism—topography-guided re-fractive treatments cannot be basedon corneal topography alone. For topography-guided treatment, re-fractive measurements of the eye’s

optical system must be obtained independently of topographic measurements. Topography-guidedtreatment software combines bothrefractive and topographic informa-tion to generate the pattern of lasershots that will improve vision.

Study summaryThe Topography-guided TreatmentStudy Group recently investigatedthe visual outcomes of topography-guided LASIK. This prospective, non-randomized study was performed at9 clinical sites in the United Statesand included 249 eyes of 212 patients with myopia or myopicastigmatism treated with topogra-phy-guided treatment LASIK usingthe WaveLight Allegretto Wave Eye-Q Laser. Outcome measures included manifest refraction, UCVA,best spectacle-corrected visual acuity(BSCVA), visual complaints, adverseevents, responses to questionnaires,and complete ophthalmologic examinations.

Patients included in this studywere between the ages of 18 and 65years (mean: 34 years) and had up to –9.0 D of spherical equivalentmyopia at the spectacle plane withup to 6.0 D of astigmatism, cor-rectible to at least 20/25 in each eye.

Doyle Stulting, MD, PhD

This supplement was produced by EyeWorld and sponsored by Alcon. Thedoctors featured in this supplement received compensation from Alcon for their contributions to this supplement.

Copyright 2014 ASCRS Ophthalmic Corporation. All rights reserved. The viewsexpressed here do not necessarily reflectthose of the editor, editorial board, or the publisher, and in no way imply endorsement by EyeWorld or ASCRS.

by Doyle Stulting, MD, PhD

Please refer to pages 6, 7, and 8 for important product information about the Alcon products described in this supplement.

“With topography-guided treatment, we should tell our patients there is anexcellent likelihoodthat they will havebetter vision withoutcorrection than theyhad preoperativelywith correction andthat the quality oftheir vision is likelyto improve.”

continued on page 3

Figure 1: Cumulative postop UCVA (ETDRS)

2 EW Boston 2014 Monday, April 28, 20142

Today, more and more sur-geons who use the LenSxLaser (Alcon, Fort Worth,Texas) are exploring the potential benefits of this

technology in challenging cases.This article details my successful use of the LenSx Laser in very densecataracts cases.

Cataract surgery in patients withvery dense cataracts represents a particular challenge. It is associatedwith a greater risk of complications.In my experience with these densecataracts, the LenSx Laser has re-duced phaco energy and balancedsalt solution use, and the procedureshave been done quickly. Beginningwith the patient docking, the lack ofa fixed bed allows us to get patientsready for the procedure quickly. Thisis especially helpful in elderly pa-tients who may have difficulty moving from lasers with a fixed bed.Even in dense cases, the averagetime from suction on to suction offhas been less than 2 minutes, andthis includes imaging, all settings,lens fragmentation, capsulotomy,and all corneal incisions.

Phacoemulsification is more efficient when the lens is treatedwith the LenSx Laser. I am confidentthat these cases benefit from re-duced corneal endothelial damageduring laser cataract surgery. TheLenSx Laser helped me in these specific cases by reducing the phacomanipulation required during sur-gery, which protected the incisionarchitecture during emulsificationand I/A.

Another concern with densecataracts is there can be high pres-sure in the bag. Because the LenSxLaser completes the treatment rap-idly, I am able to get a completerhexis. I think the LenSx Laser helps the surgeon to perform thecapsulotomy confidently. The SoftFit Patient Interface, which has a hydrogel contact lens, hasnone of the disadvantages associatedwith other contact or liquid inter-faces. I am very confident that I willget a free-floating rhexis in nearly allof my cataract cases.

Phacoemulsification of the verydense cataract presents the surgeonwith a series of specific and difficultchallenges. Many of my LenSx Laserpatients have very dense/4-grade nuclear cataracts. The LenSx Lasersuccessfully divides these nuclei intopie-shaped fragments, permitting either pre-chop or other choppingtechniques. The total power requiredfor emulsification was decreased byabout a third in my hard cataractcases. While I am able to get “zerophaco” now in routine phaco cases,I do not believe this should be theobjective. I try to focus on the out-come and use the right amount ofenergy required for each case, espe-cially in very dense cataract cases.

The LenSx Laser allows for customizable lens fragmentationbased on patients’ pathology andsurgeon preference. In these densecases, I typically use a hybrid patternthat combines cylinder and choppatterns and permits more rapid removal with reduced ultrasound.

Using the LenSx Laser inmature cataract casesby Michael Diesenhouse, MD

Michael Diesenhouse, MD

“The SoftFit PatientInterface, whichhas a hydrogel contact lens, has none of the disadvantages associated with other contact or liquid interfaces.”

The LenSx Laser offers several customizable fragmentation patterns that surgeons can select based on pathology or their preference.


The number of cuts/cylinder is customizable. Radial incisions aid in removing epi-nuclear plates. Thispattern allows me to make the deepcracks through the entire thicknessof the nucleus. Once the segmentsof the dense nucleus are fragmentedby the laser, I am able to phaco be-cause the phaco energy is deliveredmore posteriorly, and the endothe-lium is usually well-protected.

The recently released “Frag” pattern is designed to be effective in all cataract cases. This pattern will permit both horizontal and vertical segments, and because it is customizable, it will allow surgeons to adjust the size of cubes.

The LenSx Laser’s user interfaceis simple to understand and easy toadjust. I make the primary incision0.1 to 0.2 mm larger than my manual incision to ensure there isno thermal injury from the phacohandpiece. Additionally, with theLenSx Laser, the lens cortex is cutcleanly, with no strands of cortexfloating in the bag. During I/A, I go further into the fornix of thecapsular bag to grab the cortex. I recommend that surgeons approachthe subincisional cortex first to aidin cortical removal.

I’ve had good success with theLenSx Laser, even in challengingcases.

Dr. Diesenhouse is medical director of Eye Associates of Tucson and Catalina SurgeryCenter in Tucson, Ariz. He can be contacted at [email protected].

EW Boston 2014 3

Forty-four percent were men, and56% were women. Eyes with priorrefractive surgery, significant lentic-ular astigmatism, abnormal topogra-phies, a calculated residual stromalbed thickness less than 250 µm, orother ocular pathology that mightaffect the results of LASIK were excluded.

Postoperative examinationswere performed at day 1, week 1,and months 1, 3, 6, 9, and 12. Visualacuities and refractive errors weremeasured with the Early TreatmentDiabetic Retinopathy (ETDRS) chartsand protocol.

The study found that topogra-phy-guided treatment resulted in asignificant reduction in manifest re-fraction spherical equivalent (MRSE)and cylinder, reaching stability at 3months after treatment. Mean MRSEwas 0.06±0.33 D at 3 months and0.00±0.27 D at 1 year. Mean cylinderwas 0.19±0.32 D at 3 months and0.19±0.30 D at 1 year. Three monthspostoperatively, 91.9% of eyes werewithin 0.50 D of plano, and at 1year, 94.8% of eyes were within 0.50D of plano.

At 3 months postoperatively,7.7% of eyes saw 20/10 or betterwithout correction; 31.6% of eyessaw 20/12.5 or better; 68.8% of eyessaw 20/16 or better; 92.7% of eyessaw 20/20 or better; and 97.2% ofeyes saw 20/25 or better. At 1 year,15.7% of eyes saw 20/10 or betterwithout correction; 34.4% of eyessaw 20/12.5 or better; 64.8% of eyessaw 20/16 or better; 92.6% of eyessaw 20/20 or better; and 96.5% ofeyes saw 20/25 or better. Eyes treatedwith topography-guided treatmentachieved an improvement in UCVAcompared to preoperative BSCVA,with 29.6% of eyes gaining 1 ormore lines of UCVA, and 89.9% ofeyes seeing at least as well withoutcorrection postoperatively as theydid with best spectacle correctionpreoperatively (Figure 1).

The safety of topography-guidedtreatment was excellent, with only 5single reports of loss of BSCVA oftwo or more lines at 1 month orlater. One patient suffered bilateralretinal detachments 6 months aftertopography-guided treatment. Com-plications were transient and did notresult in significant loss of vision. In fact, there was a tendency towardan improvement in BSCVA after topography-guided treatment, compared to preoperatively, with atrend toward further improvementwith time (Figure 2.)

Most visual symptoms improvedat 3 months after topography-guidedtreatment compared to preoperativelevels with habitual correction,reaching statistical significance forlight sensitivity, difficulty driving atnight, reading difficulty, and glare.Only double vision and foreign bodysensation were reported as worseafter 3 months, with minimal in-creases of 0.8% and 0.4%, respec-tively. The incidence and severity of visual symptoms continued to decline during the 12 months of thestudy (Figure 3).

The Refractive Status and VisionProfile (RSVP) showed an improve-ment in all subscales and in the totalcomposite score that is computedfor each visit, including physical/social functioning, driving, visualsymptoms, optical problems, andproblems with corrective lenses that were evident at 3 months andcontinued to improve through 12months postoperatively, comparedto their vision while wearing glassesor contact lenses preoperatively. The only exception was glare at the 1-month visit, which showed a worsening that changed to im-provement at 3 months and all subsequent visits.

Published literature has indi-cated that a difference of 6 points ormore on the composite score is aclinically significant change,2 so thedifference in composite score frombaseline to each postoperative visitshowed a clinically significant im-provement in the RSVP profile, witha mean improvement that is nearly3 times the minimum threshold forclinically significant improvement at each postoperative visit, rangingfrom a change of –15.97 points at 3months to a change of –16.39 pointsat 12 months. Most of these patients(98.4%) were satisfied with their outcomes and said they would havetopography-guided treatment LASIKtreatment again.

The results of this study exceeded our expectations. Wethought that we would see goodoutcomes but did not think that topography-guided treatment on“normal” eyes without significanttopographic abnormalities would exceed the outcomes we are accus-tomed to seeing with currently avail-able treatments. To our surprise, wefound excellent UCVA, significantimprovements in BSCVA, and a reduction in visual symptoms. In fact, a majority of eyes had better

postoperative UCVA than preopera-tive BSCVA. I feel that topography-guided treatment should beconsidered as a first-line treatmentfor the reduction of myopia andastigmatism within the approvedFDA ranges.

We have come a long way withcorneal refractive surgery in the past2 decades. The days when we had towarn patients that loss of BSCVAand visual aberrations might be theprice they would have to pay forspectacle independence have passed.With topography-guided treatment,we should tell our patients there isan excellent likelihood that they willhave better vision without correc-tion than they had preoperativelywith correction and that the qualityof their vision is likely to improve.We can now be confident that

topography-guided treatment islikely to have a positive impact on quality of life of our patients.

Reference1. Summary of Safety and Effectiveness DataPMA P020050/S122. Schein, OD, et al. Patient outcomes of refractive surgery. The refractive status andvision profile. J Cataract Refract Surg. 2001;27(5):665-73.

Dr. Stulting is affiliated with the Stulting Research Center at Woolfson Eye Institute, Atlanta. He can be contacted at [email protected].

*Trademarks are property of their respectiveowners.

continued from page 1

Figure 2: Postop BSCVA compared to preop BSCVA (change in lines)

Figure 3: Visual symptoms: preop to 3 M, n=247

The Cataract Refractive Suite(Alcon, Fort Worth, Texas)features the VERION ImageGuided System,* LuxOR Microscope, LenSx Laser,

and the CENTURION Vision System.Each component of the Cataract Refractive Suite is designed to helpensure accuracy at every step of theprocedure, so that surgeons can con-sistently deliver excellent refractiveoutcomes, even in unusual or diffi-cult cases. Cases can be difficult be-cause of the anatomy of the patientor eye, and sometimes they can bedifficult because of disinhibitionfrom the relaxing medication usedduring surgery. I recently had a casein which the patient had an extraor-dinarily deep anterior chamber andhard cataract, and then turned outto be unable to cooperate very wellin the OR. Each of the componentsprovided by the Cataract RefractiveSuite was recruited to help meachieve the outcome I had hoped to achieve under normal circum-stances.

The patient was a 40-year-oldwoman with a hard cataract. Shehad 3+ nuclear sclerosis with anLOCS III grading of NO 4.2 NC 3.9. I had planned femtosecond laser-assisted cataract surgery to implant a21.5 D AcrySof IQ ReSTOR multifo-cal IOL (Alcon).

In her preop examination, weused the VERION Reference Unit to create a digital image of her conjunctival vessels and iris features,including the position of the undi-lated pupil. During surgery, thiswould confirm incision locations byprojecting them through the micro-scope oculars and assist in makingsure that the IOL was well centeredat the conclusion of the case.

Before moving into the OR, weused the LenSx Laser to accomplishthe critical steps of incision creationand capsulotomy as well as to createa chop pattern for lens dissection.Once in the OR, the patient wasprepped and draped and receivedsome relaxing medication throughthe IV. Everything was fine as weplaced the speculum, but as we wereopening the incisions with a bluntspatula, the patient started to moveexcessively and tried to reach herhands to her face. This happened repeatedly throughout the case. Toaccomplish surgery, my OR techni-cian stabilized her forehead, and theanesthetist held her arms while I repeatedly reminded her of where

Just another day at the office: How the Cataract Refractive Suite helped by James Davison, MD, FACS


Figure 1. The LenSx femtosecond laser-created 2.5-mm incision was easily openedwith a blunt dissection instrument.

Figure 2. The injection of VISCOAT folded over the free-floating anterior capsule.

Figure 3. Even with this moving patient, the CENTURION and Balanced Tip helped to provide precision and control in the deep grooving process of the firm cataract.

James Davison, MD, FACS

“In this particularcase, I had more than1,000 of my peers observing the casevia live satellite feed at the 2013American Academy of Ophthalmologymeeting, so the pressure was really on.”


she was and what we were doingand appealed for cooperation.

Fortunately, the most criticalparts of the surgery had already been accomplished before shestarted moving. It could have beendisastrous to have the patient movesuddenly while using a keratomeblade because the incision wouldthen be too large and would allowtoo much fluid outflow, whichwould rapidly produce iris traumaand miosis and shallow the anteriorchamber. If the patient had moved

during the capsulorhexis, the capsular opening would be at leastimperfect and could even extendthrough an anterior radial tear,which could become a posterior tearand could lead to a sunken nucleusand vitreous loss with no IOL im-planted. The relief of having thosesteps accomplished before things got difficult cannot be overstated.

Fortunately, I was using theLuxOR Ophthalmic Microscope, another component of the CataractRefractive Suite. One of the features

EW Boston 2014 5

make a difficult case successful

of the LuxOR Microscope is itsbroadly available red reflex. It has a six-times larger red reflex zone,greater red reflex stability, andgreater depth of focus than traditional focused light micro-scopes. Because of these LuxOR features, I didn’t need to make as many X-Y and focusing adjust-ments, and I could see what I wasdoing at all times.

Another asset of the CataractRefractive Suite is the CENTURIONVision System. This phacoemulsifi-cation machine is an intelligentphaco platform designed to dynami-cally optimize every moment ofcataract removal. It is designed toprovide a new standard in anteriorchamber stability and emulsificationefficiency. In this difficult case, theCENTURION Vision System allowedme to emulsify the firm nucleuswithin the capsular bag and irisplane. Because of its advanced flu-idics and its INTREPID Balanced Tip,the CENTURION is particularly goodat emulsifying hard fragments, andwe needed that efficiency in thiscase. Fortunately, we had used the

Figure 4. Two features were especially helpful while removing the quadrants in this moving patient:the broad-area red reflex provided by the LuxOR operating microscope and Active Fluidics from theCENTURION with its improved control and safety.

Figure 5. Bimanual control during IOL implantation was provided by the AutoSert injector cartridgeand the cyclodialysis spatula.

Figure 6. The VERION System shows that the IOL is just slightly inferior to perfect position withrespect to the preoperative pupil.

Figure 7. Dr. Davison performs live surgery at the 2013 American Academy of Ophthalmology meeting.

chop pattern during LenSx Laser nucleus dissection. This made itmuch easier to create four equallysized fragments without having tosculpt as deeply as usual. The chopwas created so that it stopped 500µm from the posterior capsule.

The AutoSert feature of theCENTURION was also beneficial inthis case because it allowed me touse both hands to control the eyeand insert the IOL in a controlledfashion. Prior to insertion, I injectedProVisc but had to open another vialto add even more in order to deepenthe anterior chamber enough tomake sure that the posterior capsulewas concave and taut. The IOL haptics could catch a flaccid flat orconvex posterior capsule and createa posterior tear and potentially asunken IOL. It would have been ashame to struggle all the way to thatpoint and then have a problem, so itwas worth it to take the time to putin extra viscoelastic. Before we introduced the I/A handpiece andsilicone tip for viscoelastic removal,we adjusted the target IOP from 55to 26 mmHg so that the eye didn’t

overinflate, pushing the IOL/capsu-lar bag complex posterior and causing pain that could have causedadditional patient movement.

After the viscoelastic was removed, we used the final compo-nent of the Cataract Refractive Suite,the VERION Image Guided System,which had received preop patientdata and images digitally from theReference Unit. The VERION systemis designed to add greater accuracyand efficiency for the incision, toricIOL orientation, as well as capsu-lorhexis and IOL optic centration.The system helped me to ensure thatthe multifocal lens was perfectlycentered on the preoperative undi-lated pupil

At the conclusion of surgery, the incisions looked good and werewatertight, and the procedure wascomplete. On postop day 1, no onewould have ever known that thecase had been challenging. The patient was happy, and everythinglooked fine, with uncorrected visionof 20/25.

We all have cases of suboptimalcooperation and anatomic challenge

like this from time to time, butthankfully all of the features of theCataract Refractive Suite helped meachieve a high-quality successfuloutcome here. In this particularcase, I had more than 1,000 of mypeers observing the case via livesatellite feed at the 2013 AmericanAcademy of Ophthalmology meet-ing, so the pressure was really on.

The Cataract Refractive Suite hasgreat value because each componentis designed to help you consistentlyachieve your targeted refractive goal.The Suite can afford criticallyneeded additional value with difficult cases such as steep brows,pseudoexfoliation, small pupils, or a patient who is not perfectly cooperative, to name a few.

Dr. Davison is in private practice at Wolfe Eye Clinic in Marshalltown and West Des Moines, Iowa. He can be contacted at [email protected].

*The VERION Image Guided System is composed of the VERION Reference Unit and the VERION Digital Marker.


AcrySof IQ Intraocular Lenses Caution: Federal (USA) law restricts this device to the sale by or on the order of a physician.

Indications: The AcrySof IQ posterior chamber intraocular lens is intended for the replacement of the human lens to achieve visual correction of aphakia in adult patients following cataract surgery. This lens is intended for placement in the capsular bag.

Warning/Precaution: Careful preoperative evaluation and sound clinical judgment shouldbe used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patientwith any of the conditions described in the Directions for Use labeling. Caution should beused prior to lens encapsulation to avoid lens decentrations or dislocations.

Studies have shown that color vision discrimination is not adversely affected in individualswith the AcrySof Natural IOL and normal color vision. The effect on vision of the AcrySofNatural IOL in subjects with hereditary color vision defects and acquired color vision defectssecondary to ocular disease (e.g., glaucoma, diabetic retinopathy, chronic uveitis, and otherretinal or optic nerve diseases) has not been studied. Do not resterilize; do not store over 45degrees C; use only sterile irrigating solutions such as BSS or BSS PLUS Sterile Intraocular Irrigating Solutions.

Attention: Reference the Directions for Use labeling for a complete listing of indications,warnings and precautions.

AcrySof IQ ReSTOR Intraocular Lenses Caution: Federal (USA) law restricts this device to the sale by or on the order of a physician.

Indications: The AcrySof IQ ReSTOR Posterior Chamber Intraocular Lens (IOL) is intendedfor primary implantation for the visual correction of aphakia secondary to removal of acataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag.

Warning/Precaution: Careful preoperative evaluation and sound clinical judgment shouldbe used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patientwith any of the conditions described in the Directions for Use labeling. Physicians shouldtarget emmetropia, and ensure that IOL centration is achieved. Care should be taken to remove viscoelastic from the eye at the close of surgery.

Some patients may experience visual disturbances and/or discomfort due to multifocality, especially under dim light conditions. Clinical studies with the AcrySof ReSTOR lens indicated that posterior capsule opacification (PCO), when present, developed earlier intoclinically significant PCO. Prior to surgery, physicians should provide prospective patientswith a copy of the Patient Information Brochure available from Alcon for this product informing them of possible risks and benefits associated with the AcrySof IQ ReSTOR IOLs.



AcrySof IQ Toric Intraocular Lenses Caution: Federal (USA) law restricts this device to the sale by or on the order of a physician.

Indications: The AcrySof IQ Toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patientswith or without presbyopia, who desire improved uncorrected distance vision, reduction ofresidual refractive cylinder and increased spectacle independence for distance vision.

Warning/Precaution: Careful preoperative evaluation and sound clinical judgment shouldbe used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patientwith any of the conditions described in the Directions for Use labeling. Toric IOLs shouldnot be implanted if the posterior capsule is ruptured, if the zonules are damaged, or if a primary posterior capsulotomy is planned. Rotation can reduce astigmatic correction; if necessary lens repositioning should occur as early as possible prior to lens encapsulation. All viscoelastics should be removed from both the anterior and posterior sides of the lens;residual viscoelastics may allow the lens to rotate.

Optical theory suggests that high astigmatic patients (i.e., >2.5 D) may experience spatialdistortions. Possible toric IOL related factors may include residual cylindrical error or axismisalignments. Prior to surgery, physicians should provide prospective patients with a copyof the Patient Information Brochure available from Alcon for this product informing themof possible risks and benefits associated with the AcrySof IQ Toric Cylinder Power IOLs.



CENTURION Vision System Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

As part of a properly maintained surgical environment, it is recommended that a backup IOL injector be made available in the event the AutoSert IOL Injector Handpiece does notperform as expected.

Indication: The CENTURION Vision system is indicated for emulsification, separation, irrigation, and aspiration of cataracts, residual cortical material and lens epithelial cells, vitreous aspiration and cutting associated with anterior vitrectomy, bipolar coagulation, and intraocular lens injection. The AutoSert IOL Injector Handpiece is intended to deliverqualified AcrySof intraocular lenses into the eye following cataract removal.

The AutoSert IOL Injector Handpiece achieves the functionality of injection of intraocularlenses. The AutoSert IOL Injector Handpiece is indicated for use with the AcrySof lensesSN6OWF, SN6AD1, SN6AT3 through SN6AT9, as well as approved AcrySof lenses that arespecifically indicated for use with this inserter, as indicated in the approved labeling of thoselenses.

Warnings: Appropriate use of CENTURION Vision System parameters and accessories is important for successful procedures. Use of low vacuum limits, low flow rates, low bottleheights, high power settings, extended power usage, power usage during occlusion conditions (beeping tones), failure to sufficiently aspirate viscoelastic prior to using power, excessively tight incisions, and combinations of the above actions may result in significanttemperature increases at incision site and inside the eye, and lead to severe thermal eye tissue damage.

Good clinical practice dictates the testing for adequate irrigation and aspiration flow prior to entering the eye. Ensure that tubings are not occluded or pinched during any phase of operation.

The consumables used in conjunction with ALCON instrument products constitute a complete surgical system. Use of consumables and handpieces other than those manufactured by Alcon may affect system performance and create potential hazards.

AEs/Complications: Inadvertent actuation of Prime or Tune while a handpiece is in the eyecan create a hazardous condition that may result in patient injury. During any ultrasonicprocedure, metal particles may result from inadvertent touching of the ultrasonic tip with asecond instrument. Another potential source of metal particles resulting from any ultrasonichandpiece may be the result of ultrasonic energy causing micro abrasion of the ultrasonictip.

Attention: Refer to the Directions for Use and Operator’s Manual for a complete listing ofindications, warnings, cautions and notes.

LenSx LaserCaution: United States Federal Law restricts this device to sale and use by or on the order ofa physician or licensed eyecare practitioner.

Indication: The LenSx Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single-plane and multi-plane arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Restrictions:

• Patients must be able to lie flat and motionless in a supine position. • Patient must be able to understand and give an informed consent. • Patients must be able to tolerate local or topical anesthesia. • Patients with elevated IOP should use topical steroids only under close medical supervision.

Contraindications:• Corneal disease that precludes applanation of the cornea or transmission of laser light at1030 nm wavelength

• Descemetocele with impending corneal rupture• Presence of blood or other material in the anterior chamber• Poorly dilating pupil, such that the iris is not peripheral to the intended diameter for thecapsulotomy

• Conditions that would cause inadequate clearance between the intended capsulotomydepth and the endothelium (applicable to capsulotomy only)

• Previous corneal incisions that might provide a potential space into which the gas produced by the procedure can escape

• Corneal thickness requirements that are beyond the range of the system• Corneal opacity that would interfere with the laser beam• Hypotony or the presence of a corneal implant• Residual, recurrent, active ocular or eyelid disease, including any corneal abnormality (for example, recurrent corneal erosion, severe basement membrane disease)

• History of lens or zonular instability• Any contraindication to cataract or keratoplasty• This device is not intended for use in pediatric surgery.

Warnings: The LenSx Laser System should only be operated by a physician trained in its use.

The LenSx Laser delivery system employs one sterile disposable LenSx Laser Patient Interfaceconsisting of an applanation lens and suction ring. The Patient Interface is intended for single use only. The disposables used in conjunction with ALCON instrument products constitute a complete surgical system. Use of disposables other than those manufactured byAlcon may affect system performance and create potential hazards.

The physician should base patient selection criteria on professional experience, publishedliterature, and educational courses. Adult patients should be scheduled to undergo cataractextraction.

Important product information

EW Boston 2014 7

Precautions:• Do not use cell phones or pagers of any kind in the same room as the LenSx Laser.• Discard used Patient Interfaces as medical waste.

AEs/Complications:• Capsulotomy, phacofragmentation, or cut or incision decentration• Incomplete or interrupted capsulotomy, fragmentation, or corneal incision procedure• Capsular tear• Corneal abrasion or defect• Pain• Infection• Bleeding• Damage to intraocular structures• Anterior chamber fluid leakage, anterior chamber collapse• Elevated pressure to the eye

Attention: Refer to the LenSx Laser Operator’s Manual for a complete listing of indications,warnings and precautions.

ProViscCaution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indication: ProVisc OVD is indicated for use as an ophthalmic surgical aid in the anteriorsegment during cataract extraction and intraocular lens (IOL) implantation. Ophthalmic viscoelastics serve to maintain a deep anterior chamber during anterior segment surgery allowing reduced trauma to the corneal endothelium and surrounding ocular tissues. Theyhelp push back the vitreous face and prevent formation of a flat chamber during surgery.

Contraindications: At present there are no known contraindications of the use of ProViscOphthalmic Viscosurgical Device when used as recommended.

Warnings/Precautions:• Postoperative increases in intraocular pressure have been reported with sodiumhyaluronate products. The IOP should be carefully monitored and appropriate therapy instituted if significant increases should occur. It is recommended that ProVisc OVD be removed by irrigation and/or aspiration at the close of surgery. Do not overfill anteriorchamber. Although sodium hyaluronate is a highly purified biological polymer the physician should be aware of the potential allergic risks inherent in the use of any biological material; care should be used in patients with hypersensitivity to any components in this material. Cannula assembly instructions should be followed to prevent patient injury.

• Postoperative inflammatory reactions such as hypopyon and iritis have been reportedwith the use of ophthalmic viscoelastics, as well as incidents of corneal edema, corneal decompensation, and a transient rise intraocular pressure.

Attention: Reference the directions for use for a complete listing of indications, warningsand precautions.

VERION Reference Unit and VERION Digital Marker Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Intended uses: The VERION Reference Unit is a preoperative measurement device that captures and utilizes a high-resolution reference image of a patient’s eye in order to determine the radii and corneal curvature of steep and flat axes, limbal position and diameter, pupil position and diameter, and corneal reflex position. In addition, the VERIONReference Unit provides preoperative surgical planning functions that utilize the referenceimage and preoperative measurements to assist with planning cataract surgical procedures,including the number and location of incisions and the appropriate intraocular lens usingexisting formulas. The VERION Reference Unit also supports the export of the high-resolution reference image, preoperative measurement data, and surgical plans for use with the VERION Digital Marker and other compatible devices through the use of a USBmemory stick.

The VERION Digital Marker links to compatible surgical microscopes to display concurrentlythe reference and microscope images, allowing the surgeon to account for lateral and rotational eye movements. In addition, the planned capsulorhexis position and radius, IOL positioning, and implantation axis from the VERION Reference Unit surgical plan canbe overlaid on a computer screen or the physician’s microscope view.

Contraindications: The following conditions may affect the accuracy of surgical plans prepared with the VERION Reference Unit: a pseudophakic eye, eye fixation problems, anon-intact cornea, or an irregular cornea. In addition, patients should refrain from wearingcontact lenses during the reference measurement as this may interfere with the accuracy ofthe measurements.

Only trained personnel familiar with the process of IOL power calculation and astigmatismcorrection planning should use the VERION Reference Unit. Poor quality or inadequate biometer measurements will affect the accuracy of surgical plans prepared with the VERIONReference Unit.

The following contraindications may affect the proper functioning of the VERION DigitalMarker: changes in a patient’s eye between preoperative measurement and surgery, an irregular elliptic limbus (e.g., due to eye fixation during surgery, and bleeding or bloatedconjunctiva due to anesthesia). In addition, the use of eye drops that constrict sclera vesselsbefore or during surgery should be avoided.

Warnings: Only properly trained personnel should operate the VERION Reference Unit andVERION Digital Marker.

Only use the provided medical power supplies and data communication cable. The power supplies for the VERION Reference Unit and the VERION Digital Marker must be uninterruptible. Do not use these devices in combination with an extension cord. Do notcover any of the component devices while turned on.

Only use a VERION USB stick to transfer data. The VERION USB stick should only be connected to the VERION Reference Unit, the VERION Digital Marker, and other compatible

devices. Do not disconnect the VERION USB stick from the VERION Reference Unit duringshutdown of the system.

The VERION Reference Unit uses infrared light. Unless necessary, medical personnel and patients should avoid direct eye exposure to the emitted or reflected beam.

Precautions: To ensure the accuracy of VERION Reference Unit measurements, device calibration and the reference measurement should be conducted in dimmed ambient lightconditions. Only use the VERION Digital Marker in conjunction with compatible surgicalmicroscopes.

Attention: Refer to the user manuals for the VERION Reference Unit and the VERION Digital Marker for a complete description of proper use and maintenance of these devices, as well as a complete list of contraindications, warnings and precautions.

VISCOATCaution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indication: VISCOAT OVD is indicated for use as a surgical aid in anterior segment procedures including cataract extraction and intraocular lens (IOL) implantation. VISCOAT OVD maintains a deep chamber during anterior segment surgeries, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissues. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery.

Contraindications: At present there are no known contraindications of the use of VISCOATOphthalmic Viscosurgical Device when used as recommended.

Warnings/Precautions:• Failure to follow “Directions for Use” on attachment of the cannula or use of an alternatecannula may result in cannula detachment.

• Precautions are limited to those normally associated with the surgical procedure beingperformed. Although sodium hyaluronate and sodium chondroitin sulfate are highly purified biological polymers, the physician should be aware of the potential allergic risksinherent in the use of any biological material.

• A transient rise in intraocular pressure in the early postoperative period may be expected due to the presence of sodium hyaluronate, which has been shown to effectsuch a rise. It is therefore recommended that VISCOAT OVD be removed from the anterior chamber by thorough irrigation and/or aspiration at the end of the surgery tominimize postoperative IOP increases. Do not overfill anterior chamber.

Attention: Reference directions for use for a complete listing of indications, warnings andprecautions.

WaveLight Excimer Laser SystemsThis information pertains to all WaveLight Excimer Laser Systems, including the WaveLightALLEGRETTO WAVE, the ALLEGRETTO WAVE Eye-Q , and the WaveLight EX500.

Caution: Federal (U.S.) law restricts the WaveLight Excimer Laser Systems to sale by or onthe order of a physician. Only practitioners who are experienced in the medical mangementand surgical treatment of the cornea, who have been trained in laser refractive surgery (including laser calibration and operation) should use a WaveLight Excimer Laser System.

Indications: FDA has approved the WaveLight Excimer Laser systems for use in laser-assistedin situ keratomileusis (LASIK) treatments for: • the reduction or elimination of myopia of up to –12.00 D and up to 6.00 D of astigmatismat the spectacle plane;

• the reduction or elimination of hyperopia up to +6.00 D with and without astigmatic refractive errors up to 5.00 D at the spectacle plane, with a maximum manifest refractionspherical equivalent of +6.00 D;

• the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D atthe spectacle plane; and

• the wavefront-guided reduction or elimination of myopia of up to –7.00 D and up to 3.00 D of astigmatism at the spectacle plane.

In addition, FDA has approved the WaveLight ALLEGRETTO WAVE Eye-Q Excimer Laser System, when used with the WaveLight ALLEGRO Topolyzer and topography-guided treatment planning software for topography-guided LASIK treatments for the reduction orelimination of up to –9.00 D of myopia, or for the reduction or elimination of myopia withastigmatism, with up to –8.00 D of myopia and up to 3.00 D of astigmatism.

The WaveLight Excimer Laser Systems are only indicated for use in patients who are 18 yearsof age or older (21 years of age or older for mixed astigmatism) with documentation of a stable manifest refraction defined as ≤0.50 D of preoperative spherical equivalent shift overone year prior to surgery, exclusive of changes due to unmasking latent hyperopia.

Contraindications: The WaveLight Excimer Laser Systems are contraindicated for use withpatients who: • are pregnant or nursing; • have a diagnosed collagen vascular, autoimmune or immunodeficiency disease; • have been diagnosed with keratoconus or if there are any clinical pictures suggestive ofkeratoconus;

• are taking isotretinoin (Accutane*) and/or amiodarone hydrochloride (Cordarone*);• have severe dry eye;• have corneas too thin for LASIK;• have recurrent corneal erosion;• have advanced glaucoma; or• have uncontrolled diabetes.

Warnings: The WaveLight Excimer Laser Systems are not recommended for use with patients who have:

• systemic diseases likely to affect wound healing, such as connective tissue disease, insulindependent diabetes, severe atopic disease or an immunocompromised status;

• a history of Herpes simplex or Herpes zoster keratitis; • significant dry eye that is unresponsive to treatment;


• severe allergies; • a history of glaucoma; • an unreliable preoperative wavefront examination that precludes wavefront-guided treatment; or

• a poor quality preoperative topography map that precludes topography-guided LASIKtreatment.

The wavefront-guided LASIK procedure requires accurate and reliable data from the wavefront examination. Every step of every wavefront measurement that may be used as thebasis for a wavefront-guided LASIK procedure must be validated by the user. Inaccurate orunreliable data from the wavefront examination will lead to an inaccurate treatment.

Topography-guided LASIK requires preoperative topography maps of sufficient quality to use for planning a topography-guided LASIK treatment. Poor quality topography maps mayaffect the accuracy of the topography-guided LASIK treatment and may result in poor visionafter topography-guided LASIK.

Precautions: The safety and effectiveness of the WaveLight Excimer Laser Systems have notbeen established for patients with:• progressive myopia, hyperopia, astigmatism and/or mixed astigmatism, ocular disease,previous corneal or intraocular surgery, or trauma in the ablation zone;

• corneal abnormalities including, but not limited to, scars, irregular astigmatism andcorneal warpage;

• residual corneal thickness after ablation of less than 250 microns due to the increased riskfor corneal ectasia;

• pupil size below 7.0 mm after mydriatics where applied for wavefront-guided ablationplanning;

• history of glaucoma or ocular hypertension of >23 mmHg;• taking the medications sumatriptan succinate (Imitrex*); • corneal, lens and/or vitreous opacities including, but not limited to cataract;• iris problems including, but not limited to, coloboma and previous iris surgery compromising proper eye tracking; or

• taking medications likely to affect wound healing including (but not limited to) antimetabolites.

In addition, safety and effectiveness of the WaveLight Excimer Laser Systems have not beenestablished for: • treatments with an optical zone <6.0 mm or >6.5 mm in diameter, or an ablation zone > 9.0 mm in diameter; or

• wavefront-guided treatment targets different from emmetropia (plano) in which thewavefront calculated defocus (spherical term) has been adjusted.

In the WaveLight Excimer Laser System clinical studies, there were few subjects with cylinder amounts >4 D and ≤6 D. Not all complications, adverse events, and levels of effectiveness may have been determined for this population.

Pupil sizes should be evaluated under mesopic illumination conditions. Effects of treatmenton vision under poor illumination cannot be predicted prior to surgery.

Adverse events and complications:

Myopia: In the myopia clinical study, 0.2% (2/876) of the eyes had a lost, misplaced, or misaligned flap reported at the 1 month examination.

The following complications were reported 6 months after LASIK: 0.9% (7/818) had ghosting or double images in the operative eye; 0.1% (1/818) of the eyes had a corneal epithelial defect.

Hyperopia: In the hyperopia clinical study, 0.4% (1/276) of the eyes had a retinal detachment or retinal vascular accident reported at the 3 month examination.

The following complications were reported 6 months after LASIK: 0.8% (2/262) of the eyeshad a corneal epithelial defect and 0.8% (2/262) had any epithelium in the interface.

Mixed astigmatism: In the mixed astigmatism clinical study, two adverse events were reported. The first event involved a patient who postoperatively was subject to blunt traumato the treatment eye 6 days after surgery. The patient was found to have an intact globe withno rupture, inflammation or any dislodgement of the flap. UCVA was decreased due to thisevent. The second event involved the treatment of an incorrect axis of astigmatism. The axiswas treated at 60 degrees instead of 160 degrees.

The following complications were reported 6 months after LASIK: 1.8% (2/111) of the eyeshad ghosting or double images in the operative eye.

Wavefront-guided myopia: The wavefront-guided myopia clinical study included 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized LASIK (Control Cohort). No adverse events occurred during the postoperative period of the wavefront-guided LASIK procedures. In the Control Cohort, one subject undergoing traditional LASIK had the axis of astigmatism programmed as 115 degrees instead of the actual 155 degree axis. This led to cylinder in the left eye.

The following complications were reported 6 months after wavefront-guided LASIK in theStudy Cohort: 1.2% (2/166) of the eyes had a corneal epithelial defect; 1.2% (2/166) had foreign body sensation; and 0.6% (1/166) had pain. No complications were reported in theControl Cohort.

Topography-guided myopia: There were six adverse events reported in the topography-guided myopia study. Four of the eyes experienced transient or temporary decreases in vision prior to the final 12 month follow-up visit, all of which were resolved by the final follow-up visit. One subject suffered from decreased vision in the treated eye, followingblunt force trauma 4 days after surgery. One subject experienced retinal detachment, whichwas concluded to be unrelated to the surgical procedure.

Clinical data

Myopia: The myopia clinical study included 901 eyes treated, of which 813 of 866 eligibleeyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was91.9%, and at 12 months was 93.9%. Of the 782 eyes that were eligible for the uncorrectedvisual acuity (UCVA) analysis of effectiveness at the 6-month stability time point, 98.3%were corrected to 20/40 or better, and 87.7% were corrected to 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported thefollowing visual symptoms at a “moderate” or “severe” level at least 1% higher at 3 monthspost-treatment than at baseline: visual fluctuations (28.6% vs. 12.8% at baseline).

Long-term risks of LASIK for myopia with and without astigmatism have not been studiedbeyond 12 months.

Hyperopia: The hyperopia clinical study included 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6months was 93.9%, and at 12 months was 69.9%. Of the 212 eyes that were eligible for theUCVA analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to20/40 or better, and 69.4% were corrected to 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visualsymptoms as “much worse” at 6 months post-treatment: halos (6.4%); visual fluctuations(6.1%); light sensitivity (4.9%); night driving glare (4.2%); and glare from bright lights(3.0%).

Long-term risks of LASIK for hyperopia with and without astigmatism have not been studiedbeyond 12 months.

Mixed astigmatism: The mixed astigmatism clinical study included 162 eyes treated, ofwhich 111 were eligible to be followed for 6 months. Accountability at 1 month was 99.4%,at 3 months was 96.0%, and at 6 months was 100.0%. Of the 142 eyes that were eligible forthe UCVA analysis of effectiveness at the 6-month stability time point, 97.3% achieved acuity of 20/40 or better, and 69.4% achieved acuity of 20/20 or better. Subjects who responded to a patient satisfaction questionnaire before and after LASIK reported the following visual symptoms at a “moderate” or “severe” level at least 1% higher at 3 months post-treatment than at baseline: sensitivity to light (52.9% vs. 43.3% at baseline); visual fluctuations (43.0% vs. 32.1% at baseline); and halos (42.3% vs. 37.0% at baseline).

Long-term risks of LASIK for mixed astigmatism have not been studied beyond 6 months.

Wavefront-guided myopia: The wavefront-guided myopia clinical study included 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront Optimized LASIK (Control Cohort). 166 of the Study Cohort and 166 of the Control Cohortwere eligible to be followed at 6 months. In the Study Cohort, accountability at 1 monthwas 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%.

Of the 166 eyes in the Study Cohort that were eligible for the UCVA analysis of effectiveness at the 6-month stability time point, 99.4% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better. Of the 166 eyes in the Control Cohort eligible for the UCVA analysis of effectiveness at the 6-month stability time point,99.4% were corrected to 20/40 or better, and 92.8% were corrected to 20/20.

In the Study Cohort, subjects who responded to a patient satisfaction questionnaire beforeand after LASIK reported the following visual symptoms at a “moderate” or “severe” level atleast 1% higher at 3 months post-treatment than at baseline: light sensitivity (47.8% vs.37.2% at baseline) and visual fluctuations (20.0% vs. 13.8% at baseline). In the Control Cohort, the following visual symptoms were reported at a “moderate” or “severe” level at least 1% higher at 3 months post-treatment than at baseline: halos (45.4% vs. 36.6% atbaseline) and visual fluctuations (21.9% vs. 18.3% at baseline).

Long-term risks of wavefront-guided LASIK for myopia with and without astigmatism havenot been studied beyond 6 months.

Topography-guided myopia: The topography-guided myopia clinical study included 249eyes treated, of which 230 eyes were followed for 12 months. Accountability at 3 monthswas 99.2%, at 6 months was 98.0%, and at 12 months was 92.4%. Of the 247 eyes that wereeligible for the UCVA analysis at the 3-month stability time point, 99.2% were corrected to20/40 or better, and 92.7% were corrected to 20/20 or better. Subjects who responded to apatient satisfaction questionnaire before and after LASIK reported the following visual symptoms as “marked” or “severe” at an incidence greater than 5% at 1 month after surgery: dryness (7% vs. 4% at baseline) and light sensitivity (7% vs. 5% at baseline). Visual symptoms continued to improve with time, and none of the visual symptoms wererated as being “marked” or “severe” with an incidence of at least 5% at 3 months or laterafter surgery.

Long-term risks of topography-guided LASIK for myopia with and without astigmatism havenot been studied beyond 12 months.

Information for patients: Prior to undergoing LASIK surgery with a WaveLight ExcimerLaser System, prospective patients must receive a copy of the relevant Patient InformationBooklet, and must be informed of the alternatives for correcting their vision, including (but not limited to) eyeglasses, contact lenses, photorefractive keratectomy, and other refractive surgeries.

Attention: Please refer to a current WaveLight Excimer Laser System Procedure Manual for acomplete listing of the indications, complications, warnings, precautions, and side effects.

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